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This document introduces the system validation of "BRAVO." It includes information on "Performance Qualification," "Data Integrity," and "Ready-to-Use System Qualification." The optical system of BRAVO is designed to achieve the highest standards of accuracy and can meet the stringent performance evaluation criteria set for benchtop devices (Ph.Eur.) and quantitative analysis (USP). [Contents] ■ Concept ■ Validated Solutions ■ 21 CFR Part 11 and Beyond ■ Performance Qualification – USP <858> & <1858>, Ph.Eur. 2.2.48, JP 2.26 ■ Data Integrity ■ Ready-to-Use System Qualification *For more details, please refer to the PDF document or feel free to contact us.
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【Other Published Content】 ■Validation Options ■System Validation Manual *For more details, please refer to the PDF document or feel free to contact us.
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Company information
The optics business started in 1960 as the infrared spectroscopy division of the Bruker Group in Germany. The range of products developed based on high design philosophy varies from dedicated machines used daily for production management and quality assurance to research models that demonstrate their power in the research and development of advanced materials. With Ettlingen, Germany, as the base for development and manufacturing, we respond to various customer needs through a global sales and service network.
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